zolmiptriptan
- Product NDC
- 68462-499
- 11-digit product format
- 684620499
- Labeler code
- 68462
- Product ID
- 68462-499_977ca814-2c55-4de0-a75e-9e42f2e86f77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zolmitriptan
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA202560
- Marketing category
- ANDA
- Marketing start
- 2013-05-14
- Substance
- ZOLMITRIPTAN
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- zolmiptriptan
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLMITRIPTAN | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2FS66TH3YW |
| Rxcui | 284201, 351134 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-499-40 | zolmiptriptan | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 14 |
| 68462-499-76 | zolmiptriptan | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ZOLMITRIPTAN | ACTIVE INGREDIENT | 2FS66TH3YW | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| ZOLMITRIPTAN | ACTIVE MOIETY | 2FS66TH3YW | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-499 | ZOLMIPTRIPTAN (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [GLENMARK PHARMACEUTICALS INC., USA] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240705_a734b368-6008-441c-ab44-5634e46be9a4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68462-499-40 | 68462049940 | 6 in 1 BLISTER PACK | | | | | | Historical |
| 68462-499-76 | 68462049976 | 1 BLISTER PACK in 1 CARTON (68462-499-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68462-499-40) | 1 blister pack | 2013-05-14 | 0000-00-00 | No | No | Current |